510(k) · Cleared
ClearedAlphard Cone Beam CT, Model X178
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Takara Belmont Corp. · JAK System, X-Ray, Tomography, Computed
Cleared on Oct 18, 2007 as substantially equivalent to K052587 (J. Morita USA, Inc., 2005) and 1 other predicate after a 35-day review. Its family tree reaches back 4 generations to 1997. 2 later devices descend from it.
- Decided
- Oct 18, 2007
- Review
- 35 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K973598 (1997). 8 ancestors in all, the oldest K945375 (1995). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 3 generations backK030450 3D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc. · 2003
- 2 generations backK051980 DVT ScannerImaging Sciences Intl., Inc. · 2005 · Recalled
- 1 generation backK063622 Finecube Dental CTThe Yoshida Dental Mfg. Co., Ltd. · 2007
- This deviceK072574 Alphard Cone Beam CT, Model X178Takara Belmont Corp. · 2007
- Descendant · cites it directly · 1 of its ownK101181 Bel-CatTakara Belmont Corp. · 2011
- Descendant · 2 generations on · 0 of its ownK123332 Naomi-CTLk Consulting Group · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K973598 | Siremobil CO2 | Siemens Medical Solutions USA, Inc. | 1997 | 1 |
| −3 | K030450 | 3D Accu-I-Tomo Xyz Slice View Tomograph | J. Morita USA, Inc. | 2003 | — |
| −2 | K051980 | DVT Scanner | Imaging Sciences Intl., Inc. | 2005 | 3 |
| −1 | K063622 | Finecube Dental CT | The Yoshida Dental Mfg. Co., Ltd. | 2007 | — |
| 0 (this device) | K072574 | Alphard Cone Beam CT, Model X178 | Takara Belmont Corp. | 2007 | — |
| +1 | K101181 | Bel-Cat | Takara Belmont Corp. | 2011 | — |
| +2 | K123332 | Naomi-CT | Lk Consulting Group | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JAK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052587 | 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 ExfSummary page 1…Dental Cone Beam CT Classification Name: Computed Tomography X-Ray System Product Code 90 OAS Common/Usual Name: Dental CT 2. Equivalent legally marketed device: K052587 3D Accu-I-tomo XYZ Slice View Tomograph, manufactured by MORITA and K063622 Fine Cube, manufactured by YOSHIDA 3. Indicati… | 2005 |
| * | K063622 | Finecube Dental CTSummary page 1…roduct Code 90 OAS Common/Usual Name: Dental CT 2. Equivalent legally marketed device: K052587 3D Accu-I-tomo XYZ Slice View Tomograph, manufactured by MORITA and K063622 Fine Cube, manufactured by YOSHIDA 3. Indications for Use (intended use) Alphard is an x-ray device (cone beam computed to… | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101181 | Bel-Cat | 2011 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 8 ancestors have a recall of any class.
- Of its descendants, K101181 (Takara Belmont Corp., 2011) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K052587.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
Alphard Model X1 78 is an x-ray device (cone beam computed tomography) that acquires a single 360 degree rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support. The device is operated and used by physicians, dentists, and x-ray technologists.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072574 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072574: Alphard Cone Beam CT, Model X178.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072574
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026